Center
for Drug Evaluation &
Research (CDER) News |
(CBER) Center
for Biologics Evaluation & Research |
Center
for Device & Radiological
Health (CDRH) |
Federal Register -
Meetings, Notices, & Rule Changes |
|
View CDER Handbooks |
View CBER Handbooks |
View CDRH Handbooks |
|
January 4,
2008
January 3,
2008
January 2,
2008
December
31, 2007
- Best
Pharmaceuticals for Children Act
of 2007:
List of Determinations Including
Written Request (updated)
- FDA warns
consumers not to use Super
Shangai, Strong Testis, Shangai
Ultra, Shangai Ultra X, Lady
Shangai, and Shangai Regular
(also known as Shangai
Chaojimengnan).
MedWatch Safety Information
-
New and Generic
Drug Approvals
-
Balsalazide
Disodium Capsules, Mylan
Pharma, Approval
-
Balsalazide
Disodium Capsules, Apotex,
Approval
-
Balsalazide
Disodium Capsules, Roxane
Labs, Approval
-
Diclofenac
Sodium Ophthalmic Solution,
Bausch & Lomb, Approval
-
Diclofenac
Sodium Ophthalmic Solution,
Nexus Pharma, Approval
-
Cetirizine
Hydrochloride Tablets, Par
Pharma, Approval
-
Cetirizine
Hydrochloride Tablets, Mylan
Pharma, Approval
-
Cetirizine
Hydrochloride Tablets,
Ranbaxy, Approval
-
Cetirizine
Hydrochloride Tablets,
Sandoz Inc., Approval
-
Cetirizine
Hydrochloride Tablets,
Caraco Pharma, Approval
-
Cetirizine
Hydrochloride Tablets,
Apotex, Approval
-
Cetirizine
Hydrochloride Tablets,
Actavis Elizabeth, Approval
-
Cetirizine
Hydrochloride Tablets,
Wockhardt, Approval
-
Pravastatin
Sodium Tablets, Glenmark
Pharma, Control Supplement
-
Pravastatin
Sodium Tablets, Cobalt Labs,
Control Supplement
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January 4, 2008 |
 |
FDA
Clears First Test
Designed to Detect
and Identify 12
Respiratory Viruses
from Single Sample
 |
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January 2, 2008 |
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FDA
Clears First Quick
Test For
Drug-Resistant Staph
Infections
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Federal Register:
Guidance for
Industry and Food
and Drug
Administration;
Interactive Review
for Medical Device
Submissions:
510(k)s, Original
PMAs, PMA
Supplements,
Original BLAs, and
BLA Supplements;
Availability.
 |
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|
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Weekly CFR Rule Changes -
526 - 558
- 201 -
208 - 209 |
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Friday,
Jan. 4 2008 |
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RULES
Intramammary Dosage Form New
Animal Drugs; Pirlimycin,
811 [E725606]
[TEXT] [PDF]
New Animal Drugs For Use in
Animal Feed: Semduramicin,
811813 [E725605]
[TEXT] [PDF]
NOTICES
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals,
865868 [E725593]
[TEXT] [PDF]
Draft Guidance for Industry
on Antibacterial Drug
Products: Use of
Noninferiority Studies to
Support Approval,
868869 [E725601]
[TEXT] [PDF]
Request for Comments on the
Science and Technology
Report; Establishment of
Docket; Request for
Comments,
869870 [E725607]
[TEXT] [PDF]
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Thursday,
Jan. 3, 2008 |
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RULES
Human Drugs:
Toll-Free Number for
Reporting Adverse Events on
Labeling,
402404 [E725426]
[TEXT] [PDF]
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Wednesday,
Jan. 2, 2008 |
|
NOTICES
Organization,
functions, and authority
delegations:
Center for Food Safety and
Applied Nutrition,
191194 [076257]
[TEXT] [PDF]
Reports and
guidance documents;
availability, etc.:
Interactive review for
medical device submissions:
510 (k)s, Original PMAs,
PMAs supplements, original
BLAs, and BLAs supplements,
194196 [076268]
[TEXT] [PDF]
Labeling of nonprescription
human drugs marketed without
approval of the Dietary
Supplement and
Nonprescription Drug
Consumer Protection Act; Qs
& As,
196197 [076267]
[TEXT] [PDF]
Questions and answers
regarding the labeling of
dietary supplements as
required by the Dietary
Supplement and
Nonprescription Drug
Consumer Protection Act,
197200 [076266]
[TEXT] [PDF]
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Tuesday,
Jan. 1, 2008 |
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NONE
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Monday,
Dec. 31, 2007 |
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NONE
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Combination Product
handbook |
|
US GMP Training Booklet |
|
Std. GMPs
- Parts 11, 210, 211, 820 &
ICH Q7 |
|
Med. Device - 11, 50,
54, 56, 807, 812, 814, 820,
510k/PMA |
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Clinical GCP - Parts 11,
50, 54, 56, 312, 314 & ICH
E2A & E6 |
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Multi-US GMPs 11, 58,
210/211, 600, 601, 610
& 820 |
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Parts 210/211 - Drug
GMPs |
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>210/211
with Part 11 |
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>210/211
with Part 820 |
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>210/211
with Parts 820 & 11 |
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